A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis

• BMS-986528 (Drug): Specified dose on specified days

Primary outcomes

• Number of participants with treatment-emergent adverse events (TEAEs) [Up to Week 54]
• Number of participants with Serious Adverse Events (SAEs) [Up to Week 54]

Secondary outcomes

• Maximum observed concentration (Cmax) [Up to Week 54]
• Time of maximum observed concentration (Tmax) [Up to Week 54]
• area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Up to Week 54]
• Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Up to Week 54]
• Apparent terminal serum half-life (T-HALF) [Up to Week 54]
• Apparent total body clearance (CLT/F) [Up to Week 54]
• Apparent volume of distribution of terminal phase (Vz/F) [Up to Week 54]
• Change from baseline in numbers and fractions of B cells [Up to Week 54]
• Change from baseline in immunoglobulin G (igG) levels [Up to Week 54]
• Change from baseline in igM levels [Up to Week 54]
• Change from baseline in igE levels [Up to Week 54]
• Change from baseline in igD levels [Up to Week 54]
• Change from baseline in igA levels [Up to Week 54]
• Number of participants with anti-drug antibody (ADA) [Up to Week 54]
• Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP) [At Week 12]

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria

\- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.

Exclusion Criteria

* Juvenile arthritis or onset of inflammatory arthritis before age 18.
* Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.
* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.
* Other protocol-defined Inclusion/Exclusion criteria apply.

• Bristol-Myers Squibb, Study director, Bristol-Myers Squibb

NIH grants: 2025